Kornimate/medical-research-clean huggingface dataset:
parent-delivered massage in paediatric cancer

Conditions: Anxiety; Depression; Stress; Pediatric Cancers

Summary: the purpose of this study is to determine how parents of children with cancer rate a parent-delivered massage therapy educational program for usability and satisfaction, and if massage therapy, provided by parents to their child with cancer, reduce symptoms of anxiety and depression in the child, and parenting stress in the parent.

in canadian children aged 0-19, the number of new cancer cases from 1997-2001 was on average 1,285 children per year for a total of 6,427 children over a five year period. individual and family responses to a child's or adolescent's cancer diagnosis and treatment include psychological, sociocultural and biological dimensions. parents of children with cancer can experience severe emotional distress including anxiety and depression. parents require support and skills to reduce their own anxiety and distress and to help alleviate suffering in their children. this is a two-phase research project: phase i: development of a standardized educational intervention on video/dvd to teach parents how to massage their child with cancer; phase ii: test the feasibility of the developed intervention with children with cancer and their parents. a total of 24 parents and their children with cancer who are under the care of the paediatric oncology units at the stollery children's hospital (edmonton) will be recruited for the study. it is hypothesized that this research on an educational program in parent-delivered massage therapy will directly improve the lives of children with cancer and their parents.

Eligibility criteria:
inclusion criteria: * children aged 6 to 18 years * children with a life expectancy of at least 12 weeks * children who are currently receiving active cancer care exclusion criteria: * children under the age of 6 * children with a life expectancy of less than 12 weeks * children not currently receiving active cancer care

Keywords: anxiety depression stress cancer symptoms pediatric cancer massage parent delivered massage
combination intervention to enhance treatment engagement and viral suppression among sexual and gender minority youth in nigeria

Conditions: HIV

Summary: the study will adapt and test a combination peer navigation and mhealth approach, intensive combination approach to rollback the epidemic in nigeria (icare nigeria), to improve hiv treatment engagement, medication adherence and viral suppression among ymsm and ytw, ages 15-29.

the study will adapt and test a combination peer navigation and mhealth approach, intensive combination approach to rollback the epidemic in nigeria (icare nigeria), to improve hiv treatment engagement, medication adherence and viral suppression among young men who have sex with men (ymsm) and young transgender women (ytw), ages 15-29. the 24-week pilot study will randomize participants at a ratio of 1:1 to the intervention or control. the goals of the pilot study are to assess: a) whether the intervention worked as intended (initial efficacy); and b) the feasibility, satisfaction, and acceptability among the target population of ymsm and ytw receiving hiv care in the community setting. specific aims are to: 1. adapt the icare nigeria hiv clinic-based intervention to a community-based outreach approach for ymsm and ytw ages 15-29 in ibadan, nigeria. this process will be structured using best practices for adaptation of evidence-based intervention, including distillation of adaptable components and incorporation of feedback from stakeholders, following user-centered principles of iterative design. 2. in a randomized controlled trial, test the adapted icare intervention for initial efficacy, feasibility, satisfaction, and acceptability among ymsm and ytw in the key population (kp)-focused community settings. the primary outcome will be viral load suppression (viral load\<200 copies/ml). secondary outcomes include antiretroviral drug adherence, and treatment retention via abstraction of medical records. 3. evaluate implementation indicators based on re-aim (reach, adoption, implementation, maintenance) to improve external validity and to inform sustainability and scalability of the adapted icare nigeria intervention. a mixed methods approach will be used to collect data for implementation outcomes from interventionists, intervention participants, and representatives of kp-friendly community centers.

Eligibility criteria:
inclusion criteria: * hiv seropositive * registered as a patient at one of the collaborating key population (kp)-focused community centers * male sex at birth * identify as ymsm or ytw (or report a history of sex with men) * on art for at least 3 months * understand and read basic english, yoruba, or pidgin english * intention to remain a patient at a collaborating clinic during the 24-week follow-up period * has a cellphone exclusion criteria: * unable to obtain parental permission if 15 years of age and not emancipated
extension study of ctap101-cl-3001 or ctap101-cl-3002

Conditions: Chronic Kidney Disease; Hyperparathyroidism, Secondary; Vitamin D Deficiency

Summary: this extension study of subjects previously enrolled in studies ctap101-cl-3001 or ctap101-cl-3002 allows long term evaluation of the safety and efficacy of ctap101 capsules in reducing elevated intact parathyroid hormone (ipth) and correcting vitamin d insufficiency in stage 3 or 4 chronic kidney disease patients.

only subjects previously enrolled in studies ctap101-cl-3001 or ctap101-cl-3002 are eligible to participate in this extension study. this is a phase 3, open-label study of ctap101 capsules, with and without add-on vitamin d hormone therapy.

Eligibility criteria:
inclusion criteria: * completed either of the phase 3 double-blind, placebo-controlled studies, ctap101-cl-3001 or ctap101-cl-3002 * taking no more than 1000 mg/day of elemental ca and willing/able to remain on this dose for the duration of the study * taking no more than 1600 iu/dose vitamin d (ergocalciferol or cholecalciferol) therapy and willing/able to remain on a stable dose of vitamin d during the study * willing and able to comply with study instructions and to commit to all clinic visits for the duration of the study * female subjects of childbearing potential must be neither pregnant nor lactating and must have a negative urine pregnancy test * all female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study * have the ability to read and understand subject informed consent form (icf). subjects or their legal representatives must sign the icf. exclusion criteria: * use of pharmacological dose of ergocalciferol and cholecalciferol (monthly equivalent of 50,000 iu or 1250 µg, eg, drisdol®) or bisphosphonate therapy * use of other bone metabolism therapy (with the exception of stable doses of bisphosphonates and denosumab \[xgeva® and prolia®\]) that may interfere with study endpoints * concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis that in the opinion of the investigator may worsen and/or interfere with participation in the study * neurological/psychiatric disorder, including psychotic disorder or dementia, or any condition reason which, in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely * known or suspected hypersensitivity to any of the constituents of either investigational product (ctap101) or adjunctive vitamin d hormone therapy

Keywords: parathyroid diseases renal insufficiency kidney failure, chronic hyperparathyroidism, secondary vitamin d hyperparathyroidism kidney diseases kidney failure renal insufficiency, chronic
home blood pressure monitoring before and after covid-19 vaccination in patients at high risk of cardiovascular disease

Conditions: Pain; Fatigue; Headache; Myalgia; Chills; Arthralgia; Fever

Summary: the coronavirus sars-cov-2 causing covid-19 was pandemic since 2020. vaccination is one of the most important measure to control the outbreak. the countries of the world started the vaccination since december, 2020. taiwan started since march, 21st, 2021. currently, taiwanese people receive covid-19 vaccination by either az or moderna; pfizer/bnt vaccine may import in the near future. the side effects post vaccination including injection site pain, fatigue, headache, myalgia, chills, arthralgia, fever, and so on. incidence of side effects more frequent in young people than elders; more frequent in the first dose than second dose in az vaccine; more frequent in the second dose in moderna or pfizer/bnt vaccine. taiwan v-watch is a system monitored by cdc for people proactive notification of side effects post covid-19 vaccination. but it doesn't include the objective cardiovascular parameters, for example, heart rate, arrhythmia, blood pressure, central body temperature (ear temperature) and blood oxygen saturation level. this study aims to monitor the physiologic and psychologic effects, and side effects before and after covid-19 vaccination in patients at high cardiovascular risk, including hypertension, hyperlipidemia, and type 2 diabetes, and arrhythmia or coronary artery disease. the investigators arrange two weeks of continuous home bp/hr monitoring (7 days pre- and post-vaccination) for evaluation of physiologic effects post vaccination. due to fever noted in some people post-vaccination, the investigators also measure ear temperature, pulse oximetry, and environmental temperature and humidity, for the reference of bp monitoring. in conclusion, this study may provide important information of cardiovascular response and psychosocial effects after sars-cov-2 vaccination for proactive prevention of cardiovascular complications.


Eligibility criteria:
inclusion criteria: * people at high cardiovascular risk. * clinical diagnosis of hypertension * clinical diagnosis of hyperlipidemia * clinical diagnosis of type 2 diabetes * clinical diagnosis of arrhythmia * clinical diagnosis of coronary artery disease * patients at the cardiology clinic. exclusion criteria: * people who have been diagnosed by a doctor as unsuitable for vaccination. * people with serious injuries or catastrophic illness, such as cancer patients. * people who stay in bed for a long time and cannot take care of themselves.

Keywords: covid-19 vaccination, side effects
ventilation using a bag valve mask with supplemental external handle

Conditions: Apnea

Summary: investigators compared tidal volumes for single rescuer ventilation using a modified bag valve mask with a supplemental external handle versus a conventional bag valve mask in a manikin model.

this was a prospective, randomized, crossover study to assess the tidal volume delivered using a standard and modified bag valve mask (bvm) device in a manikin airway model. the modified device comprised a standard bag valve mask with supplemental external bar. data was collected during may 2016 at the san antonio military medical center. emergency medicine providers (physicians, physician assistants, residents, nurses, medics) were randomized to device order. prior to participation each participant filled out a survey indicating their job status, gender, years of medical experience, and experience level with bvm ventilation. hand grip strength and size (length, width, span) were measured. each participant was then asked to provide bvm ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. tidal volume of each delivered breath was recorded in milliliters. after a 3 minute rest period, testing was repeated with the second device. after ventilation with each device, participants completed an anonymous questionnaire that used a likert scale to assess perceived qualities of the modified device including ease of use, ability to provide a superior mask seal, willingness to use in an emergency situation, and overall preference between the two devices. each participant served as his/her own control.

Eligibility criteria:
inclusion criteria: * emergency department healthy volunteers (physician assistants, residents, paramedics, nurses, medics, respiratory therapists). exclusion criteria: * not trained in basic life support
the comparison between the pvam and cpvi for the patients of paf

Conditions: Atrial Fibrillation; Pulmonary Vein Isolation

Summary: to compare the efficacy and safety of circumferential pulmonary vein isolation without contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial fibrillation.

this is a single centre, prospective control study. the study will enroll 180 patients with 2:1 grouped.

Eligibility criteria:
inclusion criteria: * patients with paroxysmal atrial fibrillation refractory to drugs * with consent exclusion criteria: * lvef\<50% * history of cardiac surgery * valvular heart disease * abnormal thyroid function * left atrial thrombus

Keywords: atrial fibrillation pulmonary vein isolation contact force antrum
chidamide in combination with vincristine metronomic chemotherapy for advanced triple-negative breast cancer

Conditions: Breast Cancer; Chemotherapy Effect

Summary: the mechanism of action of cidabenamide and the advantages of vincristine metronomic chemotherapy make it possible to combine the two drugs. therefore, it is necessary to conduct a prospective study to investigate the value of chidamide in combination with vincristine metronomic treatment for triple-negative breast cancer.

the mechanism of action of cidabenamide and the advantages of vincristine metronomic chemotherapy make it possible to combine the two drugs. therefore, it is necessary to conduct a prospective study to investigate the value of chidamide in combination with vincristine metronomic treatment for triple-negative breast cancer.the current study was designed to explore the efficacy of oral two-metronomic agents (chidamide in combination with vincristine) in advanced triple-negative patient in china.

Eligibility criteria:
inclusion criteria: * female; * aged ≥ 18 years and ≤75 years; * histologically proved metastatic triple-negative breast cancer; * at least one measurable or evaluable lesion based on recist 1.1 criteria; * estimated life expectancy ≥ 3 months; (6) normal heart, liver, and kidney function; * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1; - * informed consent signed by the participants. exclusion criteria: * received neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine within one year prior to treatment initiation; * participated in other new drug clinical trials within 4 weeks before enrollment; * inflammatory breast cancer; * symptomatic visceral disease; * second primary malignancy; * mental disorder.

Keywords: breast cancer metronomic treatment
effect of maraviroc (mcv) on the immunological recovery of hiv-1 discordant patients with cd4 lymphocyte counts below 200 cells/mm3

Conditions: HIV-1 Infection

Summary: maraviroc is an antiretroviral drug that belongs to the family of the ccr5 coreceptor inhibitors. it has proven to be effective in increasing cd4 lymphocyte counts in both in treated and naïve patients, irrespective of the viral load. the investigators hypothesize that adding maraviroc to the antiretroviral treatment of discordant patients, defined as those having cd4 lymphocyte counts below 200 cells /mm3 during the last year, could lead to its immunological recovery. 60 patients will be included in this unicentric, prospective, randomized and stratified clinical trial. they will be randomized to either continue with its usual high activity antiretroviral therapy (haart) treatment or to receive 300 mg of maraviroc every 12 hours plus its usual treatment. after 24 weeks, lymphocyte counts will be assessed, as well as safety, clinical progression, immunological profile of the patients and the potential benefit of maraviroc for hiv+ cirrhotic patients.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * hiv infection * patients receiving haart treatment for at least one year with a sustained viral load equal or below 200 copies/ml * viral load equal or below 200 copies/ml at the screening visit * discordant patients: patients without an increment over 50 copies /ml of cd4 lymphocytes during the last year * patients with an expected adherence to hiv treatment over 90% according to their physician. * signed informed consent form exclusion criteria: * pregnancy or breast feeding or women planning pregnancy during the study duration * any contraindication to treatment with maraviroc * x4 tropism at inclusion

Keywords: hiv-1 infection maraviroc cd4 lymphocyte count
patient specific optimized therapy post-market clinical follow-up study

Conditions: Arrythmia

Summary: study to evaluate the safety and procedural performance of the kodex - epd system when used in the treatment of cardiac arrhythmias. an additional objective is to develop patient specific optimized therapy (psot pmcf) via machine learning to improve future treatment of cardiac arrhythmias (psot).

psot pmcf is a prospective, multi-center, non-randomized, open label, single arm observational/ registry clinical study. consented subjects who are scheduled to undergo an ablation procedure due to an arrhythmia will be enrolled in the clinical study. the clinical study consists of a standard-of-care index ablation procedure and following up subjects for 12 months to evaluate product safety. the index ablation procedure will be performed using the kodex - epd system in conjunction with compatible therapeutic and diagnostic catheters. electrophysiologists should follow current, local, and expert consensus guidelines when treating subjects. the psot sub-study secondary system is a sub-study of the psot pmcf study. the objective of the sub-study is to collect data for the evaluation of the performance of new software features via a secondary system in subjects undergoing standard of care catheter-based endocardial mapping for cardiac arrhythmia's using a commercial kodex epd mapping system. the kodex-epd system in this clinical investigation will have a primary/secondary configuration. data collection and processing will be done on the primary system in the interventional lab with market released software and the primary system will be used to guide therapy. data from the primary system will be transferred to a second (secondary) workstation in the control/observation room via unidirectional communication and data on the secondary system will be processed with non-released software. results from this sub-study will be used to support the development and refinement of new software features. it is not the purpose of this sub-study to obtain ce mark. the primary endpoint of the sub-study is data collection of the kodex-epd non-released features from a secondary system.

Eligibility criteria:
inclusion criteria: 1. . subjects who are eligible for an ablation procedure based on local guidelines, 2. . subjects must be 18 years of age or above and at a legal age to give informed consent specific to state and national laws 3. . subjects must be able and willing to comply with all follow-up requirements exclusion criteria 1. . women who are pregnant (as evidenced by pregnancy test if pre-menopausal; method of assessment upon the discretion of the investigator), 2. . life expectancy less than 12 months, 3. . participation in a concurrent clinical study without prior approval from epd solutions. 4. . any contra-indication to use kodex-epd system per user manual. 5. . unrecovered/unresolved adverse events from any previous invasive procedure
identification of neuromas by high resolution ultrasound in patients with peripheral nerve injury and amputations

Conditions: Neuropathic Pain; Neuroma

Summary: neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. the role of neuromas as the cause of neuropathic pain is uncertain. in this observational cohort study, the investigators wish to explore if the prevalence of neuromas are higher in patients with pain after peripheral nerve injury and amputation, than in patients with the same conditions but without pain.


Eligibility criteria:
inclusion criteria: * subjects with peripheral nerve injury 3 months prior to participation * subjects with amputation 3 months or more prior to participation exclusion criteria: * severe somatic or psychiatric diseases * other peripheral neuropathy * lack of ability to cooperate to the clinical examination
a real-world patient-reported outcomes study in patients with long-term use of niraparib

Conditions: Ovarian Cancer

Summary: this prospective, non-interventional study is designed to evaluate the quality of life of chinese ovarian cancer patients with long-term niraparib use in a real-world setting. participants will complete questionnaires or accept telephone follow-up to provide information about their quality of life.

in this prospective, non-interventional study, patients with platinum-sensitive relapsed ovarian cancer who have received niraparib as maintenance therapy for more than two years will agree to be contacted by questionnaire or telephone three times. the interval will be 4-6 weeks. information on quality of life will be collected and analysed.

Eligibility criteria:
inclusion criteria: * age ≥18 years * histologically confirmed platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer * maintenance treatment with niraparib for ≥2 years and continuing for the next 28 days * no significant cognitive impairment * understand the trial procedure and be able to sign the informed consent form before any study-related procedures exclusion criteria: * patients who are not suitable for participation in this study according to the investigator's evaluation * patients receiving antineoplastic drugs for other malignancies * patients who are unable to comply with the protocol procedures

Keywords: patient-reported outcomes niraparib real-world ovarian cancer quality of life